NDC codes

FDA NDC Directory
Product NDC (as listed)63187-461Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0461Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63187-461-156318704611515 TABLET in 1 BOTTLE (63187-461-15)Marketed from Jan 1, 2019
63187-461-306318704613030 TABLET in 1 BOTTLE (63187-461-30)Marketed from Jan 1, 2019
63187-461-456318704614545 TABLET in 1 BOTTLE (63187-461-45)Marketed from Jan 1, 2019
63187-461-606318704616060 TABLET in 1 BOTTLE (63187-461-60)Marketed from Jan 1, 2019
63187-461-906318704619090 TABLET in 1 BOTTLE (63187-461-90)Marketed from Jan 1, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Naproxen
Generic name (nonproprietary)
naproxen
Active ingredients
Naproxen — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078250
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 63187-461_9af6ee64-084d-4ad4-9cb4-e4812c4104c0SPL ID 9af6ee64-084d-4ad4-9cb4-e4812c4104c0SPL set ID aa4d159c-9cbe-4d29-9532-33a312f1ae05RxCUI 198013UNII 57Y76R9ATQUPC 0363187461300

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463187046115 followed by a unit qualifier and the quantity

Package 63187-0461-15. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen or naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen as naproxen tablets or naproxen sodium tablets are indicated: • For the relief of the signs and symptoms of rheumatoid arthritis • For the relief of the signs and symptoms of osteoarthritis • For the relief of the signs and symptoms of ankylosing spondylitis • For the relief of the signs and symptoms of juvenile arthritis Naproxen as naproxen suspension is recommended for j…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-461

What is NDC 63187-461?
63187-461 is the product NDC for Naproxen, Naproxen 250 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naproxen.
What is the active ingredient?
Naproxen.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naproxen?
184 other product NDCs are listed under this name. See all Naproxen NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Naproxen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NaproxenNaproxen 500 mg/1TabletOralREMEDYREPACK INC.70518-475070518-4750-00
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-078467046-0784-03
NaproxenNaproxen 250 mg/1TabletOralCoupler LLC67046-049967046-0499-03
NaproxenNaproxen 375 mg/1TabletOralCoupler LLC67046-050067046-0500-03
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-050167046-0501-03
NaproxenNaproxen 375 mg/1Tablet, Delayed releaseOralSunrise Pharmaceutical, Inc.11534-21111534-0211-01
NaproxenNaproxen 500 mg/1Tablet, Delayed releaseOralSunrise Pharmaceutical, Inc.11534-21211534-0212-01
NaproxenNaproxen 250 mg/1TabletOralREMEDYREPACK INC.70518-451470518-4514-00
NaproxenNaproxen 500 mg/1TabletOralMedcore LLC82461-71182461-0711-60
NaproxenNaproxen 125 mg/5mLSuspensionOralAurobindo Pharma Limited59651-52859651-0528-47

All 185 Naproxen NDCs

Other NDCs under ANDA 078250

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078250
ProductStrengthForm · routeLabelerProduct NDC
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-0481
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-0482
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-0483
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-1583
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-1584
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-1585
NaproxenNaproxen 250 mg/1TabletOralA-S Medication Solutions50090-2788
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-7198
NaproxenNaproxen 500 mg/1TabletOralAmerican Health Packaging60687-491
NaproxenNaproxen 500 mg/1TabletOralProficient Rx LP63187-028
NaproxenNaproxen 375 mg/1TabletOralProficient Rx LP63187-535
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-153
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-807
NaproxenNaproxen 250 mg/1TabletOralCoupler LLC67046-0499
NaproxenNaproxen 375 mg/1TabletOralCoupler LLC67046-0500
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-0501
NaproxenNaproxen 250 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-188
NaproxenNaproxen 375 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-189
NaproxenNaproxen 500 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-190
NaproxenNaproxen 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8797

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